Efficacy and Safety of Endoscopic Treatment in Common Bile Duct Stone Based on the Electronic Endoscopic Surgery System: A Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of bile duct stone extraction success
研究概览
简要总结
Conventional endoscopic retrograde cholangiopancreatography (ERCP) is performed under fluoroscopic guidance, exposing endoscopists to ionizing radiation and posing risks of work-related musculoskeletal injury. Robotic-assisted ERCP may mitigate these occupational hazards and potentially enhance procedural precision and stability. However, robust clinical evidence regarding its performance and safety remains limited. This prospective, multicenter, randomized controlled non-inferiority trial is designed to evaluate the efficacy and safety of an ERCP robotic system (Electronic Endoscopic Surgery System) developed by Shanghai Aohua Photoelectricity Endoscope Co., Ltd. for common bile duct stone removal. A total of at least 200 subjects will be recruited and randomized 1:1 to either the experimental group or the control group. The experimental group will undergo robotic-assisted ERCP lithotomy using the aforementioned system, while the control group will receive conventional ERCP lithotomy using a standard duodenoscope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years, inclusive.
- •Diagnosed with common bile duct stones based on symptoms, signs, laboratory tests, and imaging examinations, and deemed suitable by the investigator for endoscopic common bile duct stone removal (lithotomy).
- •Willing to comply with all study procedures; able to understand the study purpose, and voluntarily provide written informed consent.
排除标准
- •Severe cardiac, pulmonary, renal, or hepatic insufficiency, or mental disorders.
- •Active viral hepatitis.
- •Upper gastrointestinal stenosis, obstruction, or any condition preventing endoscopic access to the descending duodenum.
- •Known intolerance to anesthetics or hypersensitivity to contrast agents.
- •Non-lithogenic obstructive acute pancreatitis or acute exacerbation of chronic pancreatitis.
- •Pregnant or lactating women.
- •Active peptic ulcer or upper gastrointestinal hemorrhage within one month prior to informed consent.
- •Known severe bleeding tendency (coagulopathy).
- •History of upper gastrointestinal reconstruction surgery resulting in altered anatomy.
- •Previous endoscopic sphincterotomy of the duodenal papilla.
- •Inability to cooperate with ERCP procedures.
- •Participation in a drug clinical trial within the past 3 months, or in another medical device clinical trial (excluding non-interventional studies) within the past month.
- •Any other condition that, in the opinion of the investigator, may render the participant unsuitable for the trial (including but not limited to duodenal mucosal edema, papillary malformation, papillary surface ulcer, papillary fistula, or difficult-to-treat stones).
研究组 & 干预措施
Conventional ERCP group
This group will undergo conventional endoscopic common bile duct lithotomy with a regular electronic duodenoscope.
干预措施: Conventional ERCP (Device)
Robotic-assisted ERCP group
干预措施: Robotic-assisted ERCP (Device)
结局指标
主要结局
Rate of bile duct stone extraction success
时间窗: Baseline
Stone extraction success was defined as complete clearance of the common bile duct during the same procedure.
Rate of adverse events
时间窗: Through study completion, an average of 1 month
次要结局
- Rate of biliary cannulation success(Baseline)
- Procedure time, including papilla localization time, cannulation time and stone extraction time(Baseline)
- Intraoperative radiation exposure time and radiation exposure dose of the principal operating investigator(Baseline)
- Success rate of external drainage(Baseline)
- Success rate of pancreatic duct stent placement(Baseline)
- Rate of intraoperative conversion(Baseline)
- Evaluation of System Performance(Baseline)
- Operational Comfort and Satisfaction Scores(Baseline)